Lumos Faces Regulatory Test After Paediatric Study Milestone Unlocks Funding
Lumos Diagnostics has hit a key enrollment milestone in its BARDA-funded paediatric study for FebriDx®, unlocking a US$720,000 payment and edging closer to FDA expansion.
- Completed Milestone 6 in BARDA-funded paediatric clinical study
- Triggered US$720,000 milestone payment, total US$1.92 million received
- Study aims to expand FebriDx® use to children aged 2-12 in CLIA-waived settings
- BARDA committed up to US$6.2 million across 12 milestones
- Potential 15-fold increase in U.S. addressable market to over US$1 billion
Lumos Hits Key Enrollment Milestone
Lumos Diagnostics Holdings Ltd (ASX: LDX) has announced the completion of Milestone 6 in its ongoing paediatric clinical study funded by the Biomedical Advanced Research and Development Authority (BARDA). This milestone, tied to patient enrollment numbers, has triggered a US$720,000 payment under the company’s contract with BARDA, bringing total milestone payments received for this study to US$1.92 million.
The study focuses on evaluating the FebriDx® rapid diagnostic device in children aged 2 to 12 years within CLIA-waived settings, a less complex clinical environment. The goal is to broaden the device’s FDA-cleared use, which currently covers patients aged 12 to 64 years, to include younger children. This expansion could significantly increase the device’s utility in paediatric care, helping clinicians differentiate bacterial from non-bacterial respiratory infections quickly and accurately.
Strategic Importance of the Study
FebriDx® is already FDA 510(k)-cleared for use in urgent and emergency care settings for adults and adolescents. The current study, expected to run for about 12 months, aims to meet statistical endpoints that will support a formal FDA submission for expanded use in younger children. Achieving a CLIA waiver would allow the device to be used in a vastly larger number of clinical sites; up to 270,000 across the U.S.; compared to the current 18,000 sites.
This expansion could increase Lumos’ U.S. total addressable market by 15 times, potentially exceeding US$1 billion. It would also provide access to approximately 60,000 clinicians treating children aged 2 to 12 years, offering a valuable diagnostic aid in managing acute respiratory infections, a common and often challenging clinical scenario.
Funding and Future Milestones
BARDA has committed non-dilutive funding totaling US$6.2 million across 12 milestones, which include clinical trial setup, patient recruitment, FDA submission, and regulatory clearances such as the 510(k) and CLIA waiver. Lumos has so far achieved milestones worth nearly one-third of this total funding, reflecting steady progress in the study.
CEO Doug Ward highlighted the operational achievement, noting the team’s strong enrolment momentum and the importance of supporting clinicians with improved diagnostic tools for children. The company plans to provide further updates as additional milestones are reached.
Broader Market Implications
If successful, the expanded use of FebriDx® in paediatric settings could reshape diagnostic approaches to respiratory infections, potentially reducing unnecessary antibiotic prescriptions and improving patient outcomes. The milestone payments and BARDA’s backing underscore the strategic value of this development for Lumos, positioning the company for significant growth in the U.S. healthcare market.
Bottom Line?
Lumos’ milestone achievement marks a pivotal step toward FDA expansion and a major market opportunity in paediatric diagnostics.
Questions in the middle?
- When will the formal FDA submission for paediatric use be lodged following study completion?
- What are the potential regulatory hurdles remaining for CLIA waiver approval?
- How will Lumos scale manufacturing and distribution if the expanded use is approved?
